- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03349593
Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population.
The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE.
Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Luleå, Sweden, 97180
- Sunderby Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.
Exclusion Criteria:
- Not signed consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypovolemia
Time Frame: One hour before surgery
|
Screening of preoperative level of venous return
|
One hour before surgery
|
Heart failure
Time Frame: One hour before surgery
|
Screening of incidence of preoperative systolic and diastolic function
|
One hour before surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tomi P Myrberg, MD PhD, Umeå University, Norrbotten county concil
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/361-31 II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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